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| eröffnet am: | 26.10.06 04:37 von: | Mme.Eugenie |
| neuester Beitrag: | 06.10.08 14:09 von: | Guido |
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NEW YORK, Oct 25, 2006 (BUSINESS WIRE) -- ImClone Systems Incorporated (NASDAQ:IMCL) announced today its financial results for the quarter and nine monthsended September 30, 2006.
Total revenues for the third quarter of 2006 were $150.7 million as comparedwith $106.5 million for the third quarter of 2005, an increase of 42%.
-- Royalty revenue of $78.6 million in the third quarter of 2006 compared with$46.6 million in the third quarter of 2005, an increase of 69%. Royalty revenuefor the third quarter of 2006 includes 39% of Bristol-Myers Squibb's in-marketERBITUX net sales of $174.6 million, compared with third quarter 2005 in-marketnet sales of $107.0 million, an increase of 63%. These in-market sales,reflecting a drop-ship distribution methodology, represent ERBITUX shipments toend-user accounts only, with no wholesaler stocking;
-- License fees and milestone revenue of $34.9 million in the third quarter of2006 compared with $27.1 million in the third quarter of 2005;
-- Manufacturing revenue of $20.9 million in the third quarter of 2006 comparedwith $10.7 million in the third quarter of 2005. The increase of $10.1 millionprincipally reflects an increase in volume purchases by Bristol-Myers Squibb.Purchases by Bristol-Myers Squibb are timed at their discretion to accommodateforecasts and safety stock needs, and are not necessarily indicative ofhistorical in-market sales or future sales expectations; and
-- Collaborative agreement revenue of $16.3 million in the third quarter of 2006compared with $22.0 million in the third quarter of 2005. The decrease of $5.7million principally reflects a reduction in clinical materials shipped to MerckKGaA versus the comparable quarter in 2005.
Total operating expenses for the third quarter of 2006 were $93.2 million,compared with $80.3 million in the third quarter of 2005. Operating expensesincluded:
-- Research and development expenses for the third quarter of 2006 were $26.4million (or $26.0 million in the third quarter of 2006 excluding stock optionexpense of $.4 million), compared with $29.0 million in the third quarter of2005. The decrease in the quarter is principally due to a reduction in clinicalmaterials sold to Merck KGaA;
-- Clinical and regulatory expenses in the third quarter of 2006 were $13.5million (or $13.2 million excluding stock option expense of $.3 million),compared with $13.6 million in the third quarter of 2005;
-- Marketing, general and administrative expenses were $16.0 million in thethird quarter of 2006 (or $14.8 million excluding stock option expense of $1.2million), compared with $19.5 million in the third quarter of 2005. The decreaseis principally attributed to lower legal fees and professional services feesfrom the comparable quarter in 2005;
-- Royalty expenses were $18.1 million in the third quarter of 2006 comparedwith $15.2 million in the third quarter of 2005 as the result of higher sales.Approximately $9.1 million and $5.5 million in 2006 and 2005, respectively werereimbursed as a component of collaborative agreement revenue, resulting in netroyalty expenses of $9.0 million for the third quarter of 2006 compared with$9.7 million in the third quarter of 2005; and
-- Cost of manufacturing revenue was $19.2 million in the third quarter of 2006compared with $3.1 million in the third quarter of 2005. The 2006 costsrepresent fully absorbed manufacturing costs, as substantially all previouslyexpensed material was sold through to our partners in 2005.
Operating income in the third quarter of 2006 was $57.5 million compared with$26.3 million in the third quarter of last year.
The effective tax rate for the full year 2006 is estimated to be approximately14%, excluding the effect of an adjustment recorded in the third quarter of 2006of approximately $1.8 million, resulting from changes in tax rates in certainjurisdictions. The resulting effective tax rate for the third quarter and ninemonths of 2006, including such adjustment, is 12.6% and 14.4%, respectively.These estimated rates exclude the release of a portion of the Company's taxvaluation allowance in the first quarter of 2006. The estimated tax rate for thequarter and full year 2006 is slightly lower than the 15% previously estimatedat the end of the second quarter of 2006.
Net income for the third quarter of 2006 was $57.3 million compared with $31.0million in the third quarter of last year. Diluted earnings per share were $.65in the third quarter of 2006 compared with $.35 in the third quarter of 2005.
Total revenues and net income for the nine months ended September 30, 2006 were$545.7 million and $324.1 million, respectively, compared with $284.7 millionand $85.8 million in the nine months ended September 30, 2005. Diluted earningsper share were $3.58 for the first nine months of 2006 compared with $.98 forthe first nine months of 2005. The results for the first nine months of 2006include the effect of the receipt of the $250 million milestone fromBristol-Myers Squibb and the partial release of the tax valuation allowancementioned above.
To provide investors with a clearer picture of the Company's growth versus lastyear, a reconciliation of non-GAAP diluted earnings per share to dilutedearnings per share prepared in accordance with GAAP is set forth below. For2006, non-GAAP diluted earnings per share for the quarter exclude the effects ofstock option expense and, for the nine months year-to-date, exclude the effectsof stock option expense and the tax benefit associated with the release of aportion of the Company's deferred asset valuation allowance in the first quarterof 2006. For 2005, non-GAAP diluted earnings per share for the third quarter andfirst nine months exclude expenses associated with the discontinuance of theCompany's small molecule research operation.
(Diluted per share amounts)
(Unaudited)
Three Months Ended Nine Months Ended
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
2006 2005 2006 2005
GAAP diluted earnings per
share $ .65 $ .35 $ 3.58 $ 0.98
Release of deferred tax
valuation allowance - - ($1.08) -
Stock option expense $ .02 - $ .06 -
Impact of discontinuance of
small molecule research - - - $ .07
------------------- -------------------
Non-GAAP diluted earnings per
share $ .67 $ .35 $ 2.56 $ 1.05
The Company believes that it is useful to present non-GAAP diluted earnings pershare financial measures because it provides investors with a more completeunderstanding of the Company's underlying operational results and trends. Youshould not consider non-GAAP diluted earnings per share financial measures inisolation or as a substitute for such measures determined in accordance withU.S. GAAP, as set forth above. Our definition of non-GAAP earnings may differfrom other such measures.
Conference Call
ImClone Systems will host a conference call with the financial community todiscuss third quarter 2006 financial results on Wednesday, October 25, 2006 at11:00 AM Eastern Daylight Time.
The conference call will be webcast live and may be accessed by visiting ImCloneSystems' website at www.imclone.com. A replay of the audio webcast will beavailable under "Earnings Webcast" in the "Investor Relations" section of theCompany's website starting shortly after the call on October 25, 2006.
Those parties interested in participating via telephone may join by dialing(800) 418-6860 domestically, or (973) 935-8756 for calls outside of Canada andthe United States, and referencing conference identification number 7985471. Atelephone replay of the conference call will be available shortly after the calluntil November 1, 2006 at midnight Eastern Daylight Time. To access thetelephone replay, dial (877) 519-4471 domestically, or (973) 341-3080 for callsoutside of Canada and the United States, and enter the conference identificationnumber 7985471.
About ImClone Systems Incorporated
ImClone Systems Incorporated is committed to advancing oncology care bydeveloping and commercializing a portfolio of targeted biologic treatmentsdesigned to address the medical needs of patients with a variety of cancers. TheCompany's research and development programs include growth factor blockers andangiogenesis inhibitors. ImClone Systems' strategy is to become a fullyintegrated biopharmaceutical company, taking its development programs from theresearch stage to the market. ImClone Systems' headquarters and researchoperations are located in New York City, with additional administration andmanufacturing facilities in Branchburg, New Jersey.
Certain matters discussed in this news release may constitute forward-lookingstatements within the meaning of the Private Securities Litigation Reform Act of1995 and the Federal securities laws. Although the company believes that theexpectations reflected in such forward-looking statements are based uponreasonable assumptions, it can give no assurance that its expectations will beachieved. Forward-looking information is subject to certain risks, trends anduncertainties that could cause actual results to differ materially from thoseprojected. Many of these factors are beyond the company's ability to control orpredict. Important factors that may cause actual results to differ materiallyand could impact the company and the statements contained in this news releasecan be found in the company's filings with the Securities and ExchangeCommission, including quarterly reports on Form 10-Q, current reports on Form8-K and annual reports on Form 10-K. For forward-looking statements in this newsrelease, the company claims the protection of the safe harbor forforward-looking statements contained in the Private Securities Litigation ReformAct of 1995. The company assumes no obligation to update or supplement anyforward-looking statements, whether as a result of new information, futureevents or otherwise.
IMCLONE SYSTEMS INCORPORATED
Consolidated Condensed Statements of Operations
(Unaudited)
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------- -------------------
2006 2005 2006 2005
--------- --------- --------- ---------
Revenues:
Royalty revenue $ 78,599 $ 46,647 $213,483 $124,810
License fees and milestone
revenue 34,948 27,146 212,807 76,171
Manufacturing revenue 20,884 10,748 68,589 29,661
Collaborative agreement
revenue 16,266 21,984 50,805 54,039
--------- --------- --------- ---------
Total revenues 150,697 106,525 545,684 284,681
--------- --------- --------- ---------
Operating expenses:
Research and development 26,437 28,958 87,013 74,564
Clinical and regulatory 13,527 13,583 43,537 31,357
Marketing, general and
administrative 15,977 19,463 56,941 53,919
Royalty expense 18,051 15,165 56,531 42,069
Cost of manufacturing revenue 19,187 3,099 61,466 4,948
Discontinuation of small
molecule research program - - - 6,200
--------- --------- --------- ---------
Total operating expenses 93,179 80,268 305,488 213,057
--------- --------- --------- ---------
Operating income 57,518 26,257 240,196 71,624
--------- --------- --------- ---------
Other income, net (8,084) (5,448) (22,094) (15,486)
--------- --------- --------- ---------
Income before income taxes 65,602 31,705 262,290 87,110
Provision for income taxes 8,286 754 (61,826) 1,308
--------- --------- --------- ---------
Net income $ 57,316 $ 30,951 $324,116 $ 85,802
========= ========= ========= =========
Income per common share:
Basic $ 0.68 $ 0.37 $ 3.86 $ 1.03
========= ========= ========= =========
Diluted $ 0.65 $ 0.35 $ 3.58 $ 0.98
========= ========= ========= =========
Shares used in calculation of
income per share:
Basic 84,335 83,785 84,013 83,561
========= ========= ========= =========
Diluted 91,915 92,136 91,974 92,287
========= ========= ========= =========
IMCLONE SYSTEMS INCORPORATED
Consolidated Condensed Balance Sheets
(Unaudited)
(in thousands)
September 30, December 31,
Assets 2006 2005
-------------- --------------
Current assets:
Cash and cash equivalents $ 15,308 $ 3,403
Securities available for sale 976,172 752,973
Inventories 58,923 81,394
Other current assets 136,657 71,348
-------------- --------------
Total current assets 1,187,060 909,118
Property, plant and equipment, net 425,750 406,595
Other assets (includes $28.2 million of
inventories) 171,978 27,702
-------------- --------------
Total assets $ 1,784,788 $ 1,343,415
============== ==============
Liabilities and Stockholders' Equity
Current liabilities $ 237,304 $ 242,119
Deferred revenue, long term 271,255 246,401
Long-term obligations 603,645 602,491
-------------- --------------
Total liabilities 1,112,204 1,091,011
Stockholders' equity 672,584 252,404
-------------- --------------
Total liabilities and stockholders'
equity $ 1,784,788 $ 1,343,415
============== ==============
SOURCE: ImClone Systems Incorporated
CONTACT: ImClone Systems IncorporatedInvestors:Andrea F. Rabney / Stefania Bethlen, 646-638-5058orMedia:David M. F. Pitts, 646-638-5058
Copyright Business Wire 2006
KEYWORD: United States
North America
New York
INDUSTRY KEYWORD: Health
Biotechnology
Oncology
Pharmaceutical
Research & Science
Professional ServicesJetzt einsteigen in
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Und die Geschichte zwischen dem Großinvestor Icahn und dem Unternehmen selbst ist auch noch lange nicht ausgestanden. Das kann noch zur Zerreißprobe für den Aktienkurs werden.
Positiv sehe ich das Übernahmeangebot von 36 USD (oder höher), dass eine gewisse Attraktivität sowie Kurssicherheit gibt.
xpfuture
Das gibt mir schon zu denken, ausserdem kontrolliert Icahn momentan 4 der 12 Aufsichtsratssitze und ist mittlerweile auch Chairman!!
mfg J.B.
IMCL - IMCLONE SYSTEMS (NASDAQ)
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'); bot=13; } < /script>Composite Indicator Trend Spotter TMBuy Short Term Indicators 7 Day Average Directional IndicatorBuy 10 - 8 Day Moving Average Hilo ChannelBuy 20 Day Moving Average vs PriceBuy 20 - 50 Day MACD OscillatorBuy 20 Day Bollinger BandsHold Short Term Indicators Average: 80% - Buy20-Day Average Volume - 2506005 Medium Term Indicators 40 Day Commodity Channel IndexBuy 50 Day Moving Average vs PriceBuy 20 - 100 Day MACD OscillatorSell 50 Day Parabolic Time/PriceBuy Medium Term Indicators Average: 50% - Buy50-Day Average Volume - 2269452 Long Term Indicators 60 Day Commodity Channel IndexBuy 100 Day Moving Average vs PriceSell 50 - 100 Day MACD OscillatorSell Long Term Indicators Average: 33% - Sell100-Day Average Volume - 2230743 Overall Average: 48% - Buy Wer mutig ist nimmt einen Long Call, bzw. einen OS.xpfuture
Imclone.png (verkleinert auf 65%)
NEW YORK (AP) -- Biopharmaceutical company Imclone Systems Inc. and Bristol-Myers Squibb said Monday two late-stage studies of Erbitux for metastatic colorectal cancer showed mixed results, succeeding in one but failing in another.
The first Phase III clinical trial compared Erbitux combined with "best supportive care" versus "best supportive care" alone in 572 patients. The disease in those patients was resistant to all available chemotherapy. The Erbitux combination improved overall survival rate.
The second Phase III clinical trial, comparing Erbitux and a type of chemotherapy called irinotecan to chemotherapy alone, showed the combination failed to meet its primary endpoint. The 1,300 patient study involved those whose disease wasn't responding to initial treatment with oxaliplatin-based chemotherapy. While progression-free survival and response rate favored the combination, overall survival was not improved.
"Efforts to interpret these confounded results are ongoing," the companies said in a statement. "A preliminary review of the data reveal that a considerable number of patients randomized to the irinotecan arm went on to receive Erbitux with or without irinotecan after failing irinotecan alone."
The studies are the first large randomized tests to examine the impact of Erbitux on overall survival in colon cancer. The drug was approved in February 2004 to treat colon cancer. It is also approved to treat head and neck cancer.
The companies said the study data will be fully analyzed and presented at an upcoming medical meeting.
Shares of Imclone shed 24 cents to $30.80 in early Nasdaq trading, while shares of Bristol-Myers were up 22 cents to $24.75 on the New York Stock Exchange
ImClone started the year off right by getting approval from the FDA to market Erbitux for head and neck cancer, as well as a positive European Union opinion on the drug for this indication later on in the first quarter. Setting the stage for more possible Erbitux label expansions later on, enrollment in three additional phase 3 trials were completed in the quarter.
In the second quarter, ImClone received a $250 million milestone payment from partner Bristol-Myers Squibb (NYSE: BMY) in conjunction with Erbitux's approval to treat head and neck cancer. As a result of this label expansion, Erbitux sales experienced renewed growth and ImClone clocked in revenues and earnings to the tune of 62% and 32% higher, respectively.
The third quarter started quietly enough, but then things started to fall apart for ImClone. A similar but potentially superior rival monoclonal antibody from Amgen was approved for marketing and will compete directly against Erbitux in colorectal cancer, and in head and neck cancer in the future.
Then a patent case contesting the ownership of the key Erbitux patents was ruled against ImClone, and now it will have to pay royalties on sales of Erbitux and potentially millions of dollars worth of damages if the case holds up on appeals (which it should). Then, ten days later, institutional investor Carl Icahn made public his intentions to seize control of the company.
At least the financial side of things turned out a little better in third quarter. Revenues were up to $150 million for the quarter on the back of 69% growth of Erbitux royalties and diluted earnings per share were 86% higher year over year, to $0.65 a share.
The fourth quarter is notable because Icahn finally got his wish and convinced three directors to resign, thus giving him and his allies control of ImClone's board of directors. In a shareholder friendly maneuver, he and the rest of the board decided to waive all options grants for the next year, but I still think he is just taking over ImClone to give himself, as largest shareholder, a lucrative buyout via a dutch auction with ImClone's over $1 billion in cash.
Overall, 2006 has offered only mixed results for ImClone. It did well on the financial side of things by growing diluted earnings per share 265% in the first nine months of the year, and it is flush with cash. But it's how it utilizes that cash that determines how well shares of ImClone perform in 2007.
Here's how our Motley Fool CAPS community rates ImClone as a potential investment:
Total Bulls
42
Total Bear
26
Bull Ratio
1.6:1
Bear Ratio
.6:1
ImClone only garnered one star out five, despite having more outperform than underperform picks. This is thanks to the high ranking of the players who have given the thumbs down on it.
Rule Breakers analyst and CAPS all-star TMFBreakerCharly sums up his bearishness on ImClone thusly: "Too much going wrong here. Amgen's Vectibix just approved and going to be priced very aggressively to take market share from Erbitux. ImClone (is) also going to have to pay IP damages and future royalties which will further erode margins. On top of that, there's trouble in the board room."
In past years ImClone has had a revolving door at the upper management level, which definitely will not help the company as it goes through it toughest operational period (post-Erbitux approval). Now that its only marketed drug is facing a strong competitive challenge, the window for either selling itself or transforming into a more diversified biotech via acquisitions is rapidly closing.
xpfuture
Außerdem gab es bereits vor einiger Zeit ein Angebot von USD 36,-/Aktie. Dies wurde vom CEO aber ausgeschlagen. Dieser sammelt in letzter Zeit kräftig ein. Mal seh´n wo das hinführt. Könnte mir Bristol M. vorstellen - hier noch ein interessanter Artikel http://biz.yahoo.com/ap/061226/biotech_yearender.html?.v=1
xpfuture
Werd sohl irgendwann verkaufen, hab schon 80% in der Tasche